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Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.

NCT00422422 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-07-11

Study results available
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Summary

Initial study in children with epilepsy to evaluate the pharmacokinetics, safety, tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to develop dosing adaptations for future studies.

Conditions

Interventions

DRUG

Brivaracetam

Oral solution Evaluation period (3 weeks up-titration): For subjects ≥8 years: * \~0.4 mg/kg bid for Week 1 * \~0.8 mg/kg bid for Week 2 * \~1.6 mg/kg bid for Week 3 For subjects \<8 years: * \~0.5 mg/kg bid for Week 1 * \~1.0 mg/kg bid for Week 2 * \~2.0 mg/kg bid for Week 3 Down-titration period (up to 2 weeks): For subjects ≥8 years: * \~0.8 mg/kg bid for Week 4 * \~0.4 mg/kg bid for Week 5 For subjects \<8 years: * \~1.0 mg/kg bid for Week 4 * \~0.5 mg/kg bid for Week 5

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States
  • Belgium
  • Czechia
  • Mexico
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00422422 on ClinicalTrials.gov